An overview of Conformity Assessment requirements and General Safety and Performance Requirements and demonstrating compliance in the Australian context.

1. Conformity Assessment Evidence
A Regulator’s Perspective
Dr Elizabeth McGrath
Medical Devices Branch
Medical Devices and Product Quality, TGA
2017 ARCS Annual Conference

2. Presentation Overview
Definition & Important Concepts
The Evidence
Change is Coming
Conformity Assessment Evidence 2

3. What is Conformity Assessment?
Conformity Assessment: The systematic examination of evidence
generated and procedures undertaken by the manufacturer, under
requirements established by the Regulatory Authority, to determine
that a medical device is safe and performs as intended by the
manufacturer and, therefore, conforms to the Essential Principles of
Safety and Performance for Medical Devices. - GHTF
Conformity Assessment Evidence 3

4. What is Conformity Assessment?
• All Devices, unless exempt, Must Undergo Conformity
Assessment according to their risk classification.
• All Devices must comply with the applicable essential
principles.
Conformity Assessment Evidence 4

5. Important Concept 1
“Begin at the beginning,” the King
said, very gravely, “and go on till
you come to the end, then stop.”
- Lewis Carroll
Regula
tor
Conformity Assessment Evidence 5

6. Important Concept 1 (continued)
DEVICE LIFECYCLE
Conformity Assessment Evidence 6

7. Important Concept 2
PREPARATION
PREPARATION
PREPARATION
Conformity Assessment Evidence 7

8. The Evidence
Conformity Assessment Evidence 8

9. The Essential Principles
• Schedule 1 – Medical Devices
Regulations
• Set out requirements relating to the
safety and performance of the
medical device
Conformity Assessment Evidence 9

10. Essential principles for safety and performance
1. Use of medical devices not to compromise
health and safety
2. Design and construction of medical devices to
conform to safety principles
3. Medical devices to be suitable for intended
purpose
General principles
Conformity Assessment Evidence 10

11. Essential principles for safety and performance
4. Long-term safety
5. Medical devices not to be adversely affected by
transport or storage
6. Benefits of medical devices to outweigh any side
effects
General principles
Conformity Assessment Evidence 11

12. Essential principles for safety and performance
7. Chemical, physical and biological properties
8. Infection and microbial contamination
9. Construction and environmental properties
10.Medical devices with a measuring function
11.Protection against radiation
Principles about design and construction
Conformity Assessment Evidence 12

13. Essential principles for safety and performance
12. Medical devices connected to or equipped with
an energy source
13. Information to be provided with medical devices
14. Clinical evidence
15. Principles applying to IVD medical devices only
Principles about design and construction
Conformity Assessment Evidence 13

14. Demonstrating
Compliance
Conformity Assessment Evidence 14

15. Demonstrating
Compliance
https://www.tga.gov.au/book-page/part-1-general-requirementsConformity Assessment Evidence 15

16. Format
• Should be easy to understand/find where
information is located!
• Documents should be searchable
• Guidance on structuring a submission
– The IMDRF Table of Contents documents
(on TGA website)
Conformity Assessment Evidence 16

17. Changes are on the way
Conformity Assessment Evidence 17

18. EU Regulatory Requirements
The new Regulations on medical devices
On 5 April 2017, 2 new Regulations on medical devices were adopted. These
replace the existing Directives.
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive 98/79/EC Commission Decision 2010/227/EU
The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the
Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the
Regulation on in vitro diagnostic medical devices.
Conformity Assessment Evidence 18

19. The Expert Panel Review of Medicines and
Medical Devices regulation
• Two reports on medicines and devices and complementary medicines and
advertising released during 2015
• Review process included discussion papers, submissions and interviews with
key stakeholders. Followed by stakeholder workshops and other meetings to
get feedback
• Department considered stakeholder feedback and advised Minister, who took
her preferred position to Cabinet
• Government intent released in May 2016 budget, and full response released on
15 September 2016
Conformity Assessment Evidence 19

20. Recommendation 20 – Continue to Align with
the EU
• Australian regulation of medical devices is, wherever
possible, aligned with the European framework,
• Where there are Australian specific requirements,
there must be a clear rationale for this
− Classification, EPs, CA Procedures, Definitions,
etc.
Conformity Assessment Evidence 20

21. Implementation and Governance
• A broad plan for implementation over 2-3 years agreed by
Government
• We will also consult closely with stakeholders in developing the finer
detail on implementation, including assessment of regulatory impacts
and fees and charges
• TGA has been empowered to work out much of the detail on how
specific changes could be implemented
– But we will need to go back to government for approval, in particular
where changes to the TGA Act or Regulations are needed
Conformity Assessment Evidence 21

22. Aligning the EPs and GSPRs
• Annex 1 of the new EU regulations
• Includes 23 ‘General Safety and
Performance Requirements’ (GSPR)
replacing ‘Essential Requirements’
• Based on the GHTF Essential Principles
2012
Conformity Assessment Evidence 22

23. GSPR Chapter I
General Requirements – GSPRs 1 - 9
• Key changes:
− Major changes regarding risk management (GSPRs 2 – 5)
• Closely aligned with ISO: 14971;
• GSPR 3 – Continuous Risk Management processes;
• GSPR 4 – Sequence of risk control procedures;
• GSPR 5 – Risk regarding usability – ergonomics, training, intended user.
− GSPR 9: Minimise risks for non-therapeutic devices (aesthetic, etc.)
Conformity Assessment Evidence 23

24. GSPR Chapter II
Requirements Regarding Design and Manufacture – GSPR 10 - 22
GSPR 10 Substances:
 Justification for CMR or endocrine-disrupting substances, when present >
0.1% (w/w);
 Guidelines on phthalates;
 Labelling requirement on devices and packaging for above substances.
– Reduce risks linked to the size and properties of particles released into
patient’s or use’s body, particularly nanomaterials.
Conformity Assessment Evidence 24

25. GSPR Chapter II
Requirements Regarding Design and Manufacture – GSPR 10 - 22
• GSPR 11 – Infection and microbial contamination
– Reduce risks from unintended cuts and pricks;
– Design to facilitate safe cleaning, disinfection and/or re-sterilisation;
• GSPR 12 – Devices incorporating a substance considered to be a
medicinal product and devices that are composed of substances or of
combination of substance that are absorbed by or locally dispersed in the
human body
– Verified with the specified requirements laid down in Directive 2001/83/EC;
– Evaluation of ADME profile, local tolerance, toxicity, interaction with other
devices.
Conformity Assessment Evidence 25

26. Chapter II
Requirements Regarding Design and Manufacture – GSPR 10 - 22
• GSPR 14 – Construction of Devices and Interaction with Environment
– designed and manufactured in such a way that adjustment, calibration, and
maintenance can be done safely and effectively.
– be designed and manufactured in such a way as to facilitate their safe
disposal and the safe disposal of related waste substances by the user,
patient or other person.
– manufacturers shall identify and test procedures and measures as a result of
which their devices can be safely disposed after use. Such procedures shall
be described in the instructions for use.
Conformity Assessment Evidence 26

27. GSPR Chapter II
Requirements Regarding Design and Manufacture – GSPR 10 - 22
• GSPR 17 - Software
– Key changes:
 software shall be developed and manufactured in accordance with the state
of the art taking into account the principles of development life cycle, risk
management, including information security, verification and validation.
 requirements for software and mobile computing platforms – considerations
for size and contrast ratio of screen, level of light and noise in environment.
 minimum hardware requirements, IT network characteristics, IT security
measures.
Conformity Assessment Evidence 27

28. GSPR Chapter II
Requirements Regarding Design and Manufacture – GSPR 10 - 22
• GSPR 18 - Active devices and devices connected to them
– Key improvements:
 Immunity to electromagnetic interference;
• (EP 12.5 – only minimise electromagnetic field generation)
 Protect, as far as possible, against unauthorised access that could hamper
the device from functioning as intended
Conformity Assessment Evidence 28

29. GSPR Chapter II
Requirements Regarding Design and Manufacture – GSPR 10 - 22
• GSPR 19 - Particular requirements for active implantable devices
– minimise risks connected with medical treatment, in particular those resulting
from the use of defibrillators or high- frequency surgical equipment.
– minimise risks which may arise where maintenance and calibration are
impossible, including:
 excessive increase of leakage currents,
 ageing of the materials used,
 excess heat generated by the device,
 decreased accuracy of any measuring or control mechanism.
Conformity Assessment Evidence 29

30. GSPR Chapter II
Requirements Regarding Design and Manufacture – GSPR 10 - 22
• GSPR 22 – Protection against the risks posed by medical
devices intended by the manufacturer for use by lay persons
(no requirement in current EPs)
− Important for home use devices,;
− Safety, performance, design and manufacture considering the
skills and means available to the lay person, easy to understand
information.
Conformity Assessment Evidence 30

31. GSPR Chapter III
Requirements Regarding Information Supplied with the Device – GSPR 23
• GSPR 23 – Information supplied by the manufacturer
– Numerous Changes, Including
– a requirement for UDI
– in the case of implantable devices, the overall qualitative and quantitative
information on the materials and substances to which patients can be exposed;
– a notice to the user and/or patient that any serious incident that has occurred in
relation to the device should be reported to the manufacturer and the competent
authority of the Member State in which the user and/or patient is established;
– Implant card and information/warnings for patients
Conformity Assessment Evidence

32. Work has already begun…
https://www.tga.gov.au/consultation/consultation-alignment-european-medical-device-regulatory-framework
Conformity Assessment Evidence 32

33. Question time…
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